The present invention relates to stents and other body insertable devices of open frame construction, and more particularly to radially expandable or radially self-expanding prostheses.
A variety of treatment and diagnostic procedures involve the use of devices intraluminally implantable into the body of the patient. Among these devices are stents, such as disclosed in U.S. Pat. No. 4,655,771 (Wallsten). This type of prosthesis, shown in FIG. 1, is a tubular, braided structure formed of thread elements wound helically in opposite directions. The stent is shown in a relaxed state, i.e. in the configuration assumed when the stent is subject to no external stress. The stent is elastically compressible to a reduced-radius, axially elongated state to facilitate an intraluminal delivery of the stent to an intended treatment site. At the site, the stent is released for radial self-expansion into contact with surrounding tissue, for example a blood vessel wall. The stent does not fully expand, but instead remains under a slight elastic compression, so that an internal elastic restoring force tends to anchor the stent within the vessel, and maintain vessel patency.
The thread elements, also called strands or filaments, form multiple intersections or crossing points, each including a pair of oppositely directed strands. At each end of the stent, oppositely directed strands are connected in pairs to form end terminations or strand couplings. The strands can be formed of metal, in which case the end terminations can be formed by welding the strands or by twisting the pairs of strands together, preferably augmented with welds. Alternatively, the strands can be formed of polymeric materials, with end terminations formed by fusing the strands or boding them with an adhesive.
As an alternative to self-expanding stents, a malleable metal such as tantalum can be wound or braided into a plastically deformable prosthesis. This device is capable of maintaining a reduced-radius state on its own to facilitate delivery, but requires a balloon or other implement to expand the prosthesis into contact with surrounding tissue at the treatment site.
FIG. 2 illustrates part of a prosthesis formed according to an alternative construction in which the strands are wound instead of braided, to form generally hexagonal cells. Adjacent cells have coextensive regions, along which pairs of the strands are wrapped helically about one another. This construction is further illustrated and explained in U.S. Pat. No. 5,800,519 (Sandock).
FIG. 3 illustrates a prosthesis formed according to another construction, illustrated and discussed in U.S. Pat. No. 6,264,689 (Colgan). Like the stent in FIG. 2, this stent features structural strands wound to form multiple helical cells. However, it differs from the device of FIG. 2, in that at some of the junctions of strands, the strands simply cross one another, rather than being twisted helically about one another.
At a distal end of the prosthesis in FIG. 3, the strands are bent to form a plurality of loops 1. These loops form relatively flexible, blunt end terminations, desirable because they more readily adjust to features of the body lumen in which the prosthesis is deployed, and they present minimal risk of injury to the surrounding tissue. Conversely, at the proximal end, pairs of strands are twisted together and ball welded at the ends, to form proximal end terminations 2.
The devices in FIGS. 1 and 2 may also be formed with distal and proximal end terminations comprising bends and twisted pairs, respectively. Alternatively, any of these devices may be formed with twisted end terminations at both the proximal and distal ends. As a further alternative, terminations at the proximal end, or at both ends, may be formed by welding the pairs of strands together, without twisting.
In any event, while these stents are well suited for a variety of procedures, the welded or twisted end terminations are disadvantageous. As compared to the rest of the prosthesis, the welded or twisted end terminations are relatively stiff and rigid, and thus more likely to poke surrounding tissue, rather than bend to accommodate the tissue. Because of the abrupt ends of the welded or twisted end terminations, the poking occasioned by their relative stiffness presents a risk of damage to tissue. Consequently, any positional adjustment of a deployed stent, particularly in the direction that the welded or twisted end terminations extend, is difficult. Another problem encountered with the twisted or welded end terminations is that adjacent twisted wire pairs may interlock when the stent is radially compressed into the delivery state, and then interfere with radial expansion of the stent at a treatment site.
When the stent or other prosthesis is constructed by bending the strands at its distal end, the situation is improved somewhat by limiting the foregoing difficulties to the proximal side. While they are reduced, these difficulties remain, most notably to prevent any substantial proximal repositioning of a deployed stent. Further, even the looped distal end of such device presents a problem that can limit its use. In particular, radial contraction of the device requires each loop to bend, primarily at its distal apex. The extent of radial reduction is limited by the extent to which each loop can be bent.
Therefore, it is an object of the present invention to provide a prosthesis of open frame construction with blunt, flexible end terminations at both of its opposite ends, to permit movement of the deployed prosthesis relative to surrounding tissue in either axial direction, with minimal risk of trauma to the tissue.
Another object is to provide a prosthesis with looped end terminations that permit radial compression of the prosthesis to a smaller diameter for intraluminal delivery.
A further object is to provide a process for fabricating a stent with the elongate strands or strand segments selectively shaped at one or both ends of the stent to provide relatively blunt and flexible end terminations.
Yet another object is to provide a stent or other prosthesis that is more readily adjustable and retrievable after its deployment in a blood vessel or other body lumen.